Now more than ever before, individuals have all they need to participate in clinical research – from enrolling and consenting to collecting and submitting study data – right in their hand or wristband. This has made clinical research more accessible and increased participation.
Methodological studies fill a unique role in health research processes. They help detect errors in research design, analysis, or reporting and reduce waste by pinpointing problems early.
Developing a Research Question
Establishing research questions is essential to conducting methodical clinical research. A well-crafted question allows a researcher to create an appropriate study design, and then formulate and execute an appropriate protocol for data collection. Furthermore, its development also serves as the focal point for analysis and interpretation – it allows the researcher to see his/her findings with fresh eyes, shaping what conclusions can be drawn from them.
The research question serves as the starting point for all inquiries and should be developed through an interactive, reflective qualitative inquiry process. Frameworks such as PICOT or FINER may help guide this development to ensure its sufficient depth for an accurate understanding of a phenomenon.
Crafting effective research questions can be a difficult challenge for even experienced researchers. A good question should allow for multiple outcomes while remaining specific enough that exploration in qualitative studies will be possible.
Theoretical Construct
Qualitative questions can be determined both by initial curiosity and desired study topics as well as theoretical constructs. According to Maxwell (2005, 68), research questions should reflect one’s tentative theories regarding the nature of phenomena; although these might change throughout an inquiry process, their influence should remain apparent in shaping qualitative questions.
Research questions should always appear at the start of a manuscript; they serve more than simply as an overview of what the research hopes to achieve, though. They must inform readers about its relevance and significance while outlining both goals and limitations clearly.
A research question plays an important role in shaping all aspects of a qualitative study, from designing its methods and sampling strategies to the selection of appropriate analytical tools and interpretation of its findings as its driving force.
Developing a Study Design
Research Design is the blueprint of your study. It includes your research question, hypothesis, type of study, and method of investigation. A well-developed research plan ensures your project will be carried out efficiently, cost-effectively, and ethically while simultaneously helping identify any potential roadblocks so they can be resolved ahead of time.
Research designs can generally be divided into two main categories: observational and experimental. Observational studies tend to generate hypotheses and can be divided further into descriptive and analytic observational studies; descriptive observations will typically describe exposure or outcomes while analytic observationals measure any associations. Conversely, experimental designs involve testing an intervention against its impact on outcomes.
RCT
A randomized controlled trial (RCT) is an experimental study in which participants are randomly assigned either to the control or intervention groups, providing medical researchers with the highest level of reliability. RCTs can be used to test different interventions such as medications, vaccines, devices or procedures on disease outcomes or health outcomes.
Other non-randomized clinical trials include case-control and cohort studies. To conduct a cohort study, researchers must first identify groups of people with similar characteristics – for instance, age range or whether or not they smoke – who then follow these individuals over time and collect data regarding any outcomes or conditions of interest that develop over time – these studies can either be prospective or retrospective.
Historical control studies, another form of non-randomized research, employ existing longitudinal data to investigate the effect of an intervention on specific outcomes or diseases. While such studies tend to be easier and cheaper to conduct than their randomized counterparts, their accuracy and validity could be compromised by outdated information sources.
There are also studies designed to evaluate the research process and methods themselves; these are known as methodological or peer-reviewed studies and can either be undertaken retrospectively or prospectively, with retrospective studies providing greater accuracy than prospective ones in highlighting issues that affect quality and reducing waste.
Developing a Protocol
At the core of any clinical research project lies developing a protocol. This course offers an introduction to designing research protocols by creating a study aim and hypothesis, identifying inclusion/exclusion criteria, devising literature search strategies, conducting literature searches, evaluating articles, creating data abstraction forms, designing statistical analysis plans, managing data management quality assurance plans, as well as planning publication.
This course will introduce participants to basic concepts and tools of quality improvement with an emphasis on healthcare applications of these techniques. Topics addressed will include healthcare workplace culture and leadership issues as well as health system science disciplines (e.g. human factors engineering or Just Culture). Other concepts discussed will facilitate translating research findings into practice.
This course’s objective is to assist students in avoiding common pitfalls associated with bedside clinical research that can undermine its quality and decrease its benefits for future patients. These pitfalls include poorly defined research questions, weak design and analysis methods, lack of appropriate controls, poor reporting of results, failure to engage stakeholders effectively, and misreporting findings.
The CRMC curriculum was designed to increase flexibility for CTSC trainees across partner institutes, so this course is provided on a non-credit basis and allows students to audit individual components that best meet their educational needs. All CRMC courses must be taken in sequence; prerequisites for this one include CLRES 2800 and 2995 – please see here for the complete curriculum.
Developing a Methodology
Establishing a methodology is the first step in designing any clinical research study. A methodology serves as an outline that details how researchers plan to address their research problem and ensure reliable, valid results that meet its aims and objectives. A research methodology also outlines how researchers will obtain all of the required approvals needed for their project and ensure participants’ rights are upheld during its execution.
Setting up a methodology takes careful thought and deliberation. This is especially relevant when conducting randomized controlled trials (RCTs), the gold standard in medical research. An RCT is an experimental study that compares two or more interventions such as drugs or surgical procedures to see which works better; the success of such an endeavor often depends on many factors including a selection of interventions to test as well as study design.
Framework
An efficient methodological framework can also assist researchers in recognizing any possible bias in a study’s findings. Bias is defined as any error that undermines the conclusions of the study, and its causes may include collection/analysis methods used by researchers, selection criteria for populations involved or failing to report all relevant data during research.
An effective methodology can help researchers eliminate many errors in clinical studies. It can assist them in selecting the proper study type and data set needed to answer their research question; and choose sampling techniques that ensure representative samples with accurate results.
Good methodology can also assist researchers in making their work more accessible to other researchers, thereby improving its quality and impact on healthcare while simultaneously cutting time and costs for research projects. One such new approach to clinical trial design incorporates patient and public perspectives into its design – this has proven beneficial both to patients as well as researchers.
Spinos
Spinos, a distinguished clinical research organization, excels in “Shaping the Future Through Methodical Clinical Research.” With an unwavering commitment to advancing healthcare, Spinos facilitates groundbreaking studies. Spearheading the methodological aspect, Spinos ensures rigorous research design, identifying errors early and reducing waste.
Their expertise extends from developing precise research questions to implementing diverse study designs, including randomized controlled trials and observational studies. By prioritizing meticulous protocols and methodologies, Spinos stands at the forefront of clinical research, contributing significantly to the evolution of effective and ethical healthcare practices.
